You've heard about selective publication: When a greater share of positive drug studies get published and fewer negative ones do. But what about skewed publication? In a New England Journal of Medicine article posted online today, researchers looked into studies of then-off-label uses of Pfizer's epilepsy drug Neurontin and found some big discrepancies between the original trial results and their published accounts.
Pfizer took issue with the NEJM article, calling it biased and saying it "cannot pass the threshold of credible scientific research." The company also stated that it never tried to mislead people about the drug's effectiveness.
According to the NEJM research, however, primary study goals became secondary goals, and some initially negative results went positive. For example, the Associated Press reports, when a company-funded study didn't meet its primary endpoint, the published version ignored or buried that result and highlighted a more positive, secondary finding instead. And as Reuters notes, in eight of the twelve published studies, the primary outcome was changed by Pfizer.
The new report is based on court documents the lead author, Kay Dickersin of Johns Hopkins, obtained as part of her agreement to testify as an expert witness in a Neurontin liability case. These documents still aren't publicly available.
Dr. Sidney Wolfe of the consumer advocacy group Public Citizen told the Associated Press that the new study is the first to look so broadly at a company's internal research versus the published versions. "In every instance, the published article made the drug look better than it would have," said Wolfe, who's also a member of the FDA's drug safety committee. "This results in harm."